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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82353

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Orthopaedics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

Z-1127-2019
Recall number
Z-1127-2019
Initiated
September 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
12639 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is the potential for debris/material to be found behind the O-rings in the neck trials.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the potential for debris/material to be found behind the O-rings in the neck trials.

Code information

lots 1212901 1218481 1226220 1230761 1230762 1700575 1781381 1812714 1817780 1860264 1865892 1874689 1874692 1874695 1885306 1899212 1899213 1910187 1979239 2002010 2024019 2043428 2043428 2078239 2078239 2102693 2102693 2129111 2129111 2153317 2153317 2153318 2153318 2153319 2153319 2153320 2153320 2163174 2163174 2249115 2249116 2252364 2274452 2275487 2284306 2284307 2309644 2309645 2309646 2336389 2336390 2362086 2362087 2380243 2384473 2384474 2386339 2401664 2401665 2416615 2416617 2416618 2465273 2465274 2465275 2465287 2490513 2490514 2513465 2513466 2526363 2526364 2539884 2539885 2565583 2572825 2572826 2602513 2602514 2605764 2605765 2643408 2643409 2648066 2648067 2673433 2673434 2691497 2691501 2739089 2739090 2749282 2749283 2774407 2774408 2774409 2774410 2795717 2795718 2795719 2811227 2811228 2811233 2811234 2836707 2836708 2836709 5001519 5001520 5001521 5001522 5005846 5005847 5008238 5008239 5009208 5016192 5016193 5016194 5016195 5016196 5019838 5019841 1812714A 1812714A

Distribution pattern

Worldwide Distribution - US Nationwide Distributed to accounts in AL AZ CA CO FL GA HI IA IL IN KY LA MA MD ME MI MN MS NC ND NH NJ NV NY OH OR PA SC TN TX UT VA WA, and WI. International distribution worldwide.

device · product 2 of 3

CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

Z-1128-2019
Recall number
Z-1128-2019
Initiated
September 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
12639 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is the potential for debris/material to be found behind the O-rings in the neck trials.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the potential for debris/material to be found behind the O-rings in the neck trials.

Code information

1212912 1216680 1230766 1700576 1812715 1812716 1817781 1860265 1865893 1874690 1874693 1874696 1885307 1899214 1899215 1910188 1979242 2002011 2024020 2043429 2043429 2078240 2078240 2102701 2102701 2129112 2129112 2153321 2153321 2153322 2153322 2153323 2153323 2153324 2153324 2173202 2173202 2284268 2284304 2284305 2309647 2309648 2309649 2336392 2336393 2384475 2384476 2386340 2401666 2416616 2416619 2416620 2465280 2465288 2481312 2490516 2511420 2526365 2565598 2565705 2565706 2572839 2572840 2605839 2605840 2609135 2609141 2643411 2643412 2673435 2673436 2673437 2691532 2691533 2739091 2739092 2749286 2774417 2774418 2774419 2795761 2795762 2795763 2811229 2811230 2811235 2811236 2836712 2836713 2836714 5002114 5002115 5002116 5005843 5005844 5005845 5012219 5012220 5016191 5017033 5017035 1812716A 1812716A

Distribution pattern

Worldwide Distribution - US Nationwide Distributed to accounts in AL AZ CA CO FL GA HI IA IL IN KY LA MA MD ME MI MN MS NC ND NH NJ NV NY OH OR PA SC TN TX UT VA WA, and WI. International distribution worldwide.

device · product 3 of 3

CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

Z-1129-2019
Recall number
Z-1129-2019
Initiated
September 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
12639 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is the potential for debris/material to be found behind the O-rings in the neck trials.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the potential for debris/material to be found behind the O-rings in the neck trials.

Code information

1216681 1216682 1230767 1230768 1230769 1700574 1700577 1781383 1812717 1817782 1860266 1865894 1874691 1874694 1874697 1885308 1899216 1899217 1910189 2002012 2024021 2043430 2043430 2065508 2065508 2078241 2078241 2102703 2102703 2102704 2102704 2129113 2129113 2142423 2142423 2153325 2153325 2153326 2153326 2173203 2173203 2249175 2249176 2249177 2252365 2274507 2284309 2284310 2309652 2309653 2309654 2336394 2336395 2362088 2362089 2380244 2384477 2384478 2401667 2416621 2416622 2424599 2465283 2465284 2465285 2465289 2487632 2490517 2490518 2513467 2515079 2526367 2526368 2565627 2565714 2565715 2572844 2572845 2572846 2609035 2609037 2617683 2617684 2643413 2643414 2673438 2673439 2673440 2691548 2691549 2749290 2761213 2795714 2795715 2795716 2811225 2811226 2811231 2811232 2823044 2836720 2836721 2836722 5002110 5002111 5002112 5002113 5005841 5005842 5008236 5008237 5009207 5012217 5012218 5016197 5016198 5017028 5017030 5019843 1812717A 1812717A

Distribution pattern

Worldwide Distribution - US Nationwide Distributed to accounts in AL AZ CA CO FL GA HI IA IL IN KY LA MA MD ME MI MN MS NC ND NH NJ NV NY OH OR PA SC TN TX UT VA WA, and WI. International distribution worldwide.